A leading medical device manufacturer introduced a new production line to their assembly facility.  The new line was designed to accommodate the simultaneous production of several makes and models of hand-held motor-driven surgical devices.  This new line was designed to apply the latest integrated manufacturing technology to optimize flexibility, efficiency, quality controls, and real-time accountability toward meeting immediate market demand for product.  The incorporation of a web-based SCADA (Supervisory Control and Data Acquisition) system was integral in realizing these advantages.

The SCADA system integrated an array of vendor proprietary PLC-driven equipment systems, as well as a network of assembly station equipment I/O (input/output), all transacted through the central PLC system for the line.  The SCADA/PLC/Ethernet network would control and monitor use of the following equipment system types:

• Promess Presses
• Custom servo-driven press fixture carousels and pneumatically controlled safety enclosure barriers
• Fixture verification systems, including Keyence vision systems and RFID readers
• Proximity switches for assembly positioning and manual asset selection
• Laser Marker and related Real Time Automation (RTA) communication module
• G.P. Reeves Grease Dispensers
• Ingersoll Rand Controllers and Torque Drivers
• AC HiPot test system

The SCADA system also provided the end users with the means to electronically process a wide range of manual operations related to the assembly process.  All of this would be monitored and controlled through Ethernet linked workstation web-browser based interfaces to the SCADA web application and its associated SQL database. The SCADA/Ethernet network would control and monitor use of the following equipment system types:

• Security, user permissions, and electronic signatures
• Electronic build order initiation and serial number assignment
• Printout of barcode and information labels for sub-assemblies and finished product
• Inventory management
• Tracking of sub-assembly and main assembly serial numbers throughout the process
• Subassembly consumption
• Serial number activation/release at its assigned workstation
• Display of controlled assembly instruction documents specific to the active product ID
• Electronic prompts and acknowledgments
• Operator comment entries
• Generation and storage of QIP (Quality Inspection Process) records
• In-process supervisory interventions

The SCADA system would manage all aspects of product serial number accountability from the acquisition of work order and serial number data from the corporate Enterprise Resource Planning (ERP) system to completion of the work order.  Lot numbers for parts and serial numbers for sub-assembly would be auto-generated by the SCADA system, and their serial numbers would be automatically entered in SCADA database inventory records.  In final assembly, an ERP generated serial number would be assigned to the individual production unit, then lot numbers and sub-assembly serial numbers would become automatically related to their parent assembly serial number in the electronic record as pieces are consumed during final assembly.  The system also recorded actions to send serial numbers offline and return them to online status in the event of scrap or rework conditions.

Assembly process steps for each specific part, subassembly, or product ID would be sequenced through an electronic build order record, configured and stored in the SCADA database.  Specified parameter values for each step would be controlled in step configuration records related to the build order record.  Build order execution would be initiated by the end-user at the designated workstation and its sequence of operations would be enforced through the SCADA application as the assembly progressed through its assigned sequence of workstations.

The results of each build order step would be recorded in accordance with the data acquisition parameters for the specific step type as configured in the SCADA system.  This data would be recorded in relationship to and in order of sequence for the product serial number and build order executed.  This set of records, stored in the SCADA database, would constitute the eDHR (Electronic Device History Record) for any lot number or serial number assembled on the production line.

The SCADA system would include an eDHR reporting component, developed using vendor provided report generation tools, which would provide the end-user with direct read-only access to the eDHR records in the SCADA database.  The tool would also provide read-only access to a controlled network directory of scanned QIP (Quality Inspection Process) documents generated from the SCADA system.  Records would be made available in readable, printable, and exportable formats via serial number select/query/display functions in a web-based front end.

The applied SCADA system features included:

• Inductive Automation, Ignition Platform
• Microsoft SQL Server
• Allen Bradley, ControlLogix PLC, Ethernet modules, and I/O modules
• Integrated PLC, I/O, and Ethernet communication with process hardware systems
• Multiple workbench dedicated PCs and peripheral hardware installations
• eDHR (electronic Device History Report) reporting tool application
• Interfaces to:
  • client’s EDMS (Electronic Document Management System) for display of approved process procedures
  • client’s AS400 ERP (Enterprise Resource Planning) system web services
  • client’s controlled QIP document repository
  • client’s testing systems (LabVIEW) database

Performance Validation professionals were called upon to validate this system to ensure quality and compliance with the Quality System Regulations and the client’s procedures and practices.

The PV Advantage

Performance Validation provided a team of dedicated Validation Specialist experienced in the delivery of validation documentation for SCADA projects.  Working closely with the client’s engineers, validation team, and quality assurance personnel, the PV Validation Specialist followed their established validation plan and user requirements to deliver the necessary system documentation and testing.

Installation Qualification (IQ) verified the installation of the:

• Allen Bradley PLC and IO hardware network installations
• Allen Bradley ControlLogix software configuration and backup
• SCADA Database Server and Application Server platform installations
• Ignition SCADA (Inductive Automation) application server software installations
• SQL Server database installations and configurations
• PC hardware installations for multiple workstations
• logical continuity (assets<>IO/PLC<>application<>database<>HMI)
• software storage and version control

Operational Qualifications (OQ) verified the functionality of the:

• integrated PLC logic and data communication functions
• logical security and electronic signatures
• permission-based HMI screen navigation
• fully integrated end-to-end build order executions with process enforcements
• negative testing and error handling
• supervisor intervention functions and related accountability
• system audit trails and process data logging for electronic device history records (eDHR)
• eDHR reporting functions and data integrity

Validation deliverables included:

• Validation Plans (and revision) for multiple interrelated projects
• User Requirements Specifications (and revision) / Requirements Trace Matrix
• Functional Design Specifications
• Code Review Reports
• development and execution of Computer System Validation Qualification tests scripts for IQ/OQ
• Production Support Plans
• Final Validation Reports

The Results

The client received a full suite of User Requirements and Functional Design Specifications documents for SCADA and PLC systems that established a consistent and coherent structure of concise information to define their systems.  This structuring of the specification documents set the course for development of the Computer System Validation qualification test scripts, and it facilitated an ease of traceability throughout the validation documentation package.

Final Validation Reports were approved on time and the SCADA system applications were released for production as scheduled.

The Benefits

As a repeat customer of Performance Validation, the client was able to capitalize on the PV team’s knowledge and experience gained from previously delivered SCADA and Computer Systems Validation (CSV) projects for this client. Client stakeholders were able to depend on the PV team to anticipate their compliance expectations and concerns, based on strong ongoing working relationships.  Also, having made the prior investment in client-specific corporate, site-based, and information systems training for the PV team, the client was able to implement PV resources into their projects with minimal ramp-up.  The client’s validation project managers and validation quality representatives were able to rely upon

PV’s  experience with the client’s electronic validation software system, which allowed the PV team to manage the documentation processes (i.e. validation planning, document development, routing, approval, and reporting) with minimal client resource effort.

The client was able to realize greater efficiency in validation project resources and schedules, due to the PV team’s ability to assimilate and integrate the client’s validation practices and procedures.   Established standards for SCADA and Computer Systems Validation (CSV) at this client facility, some of which were the result of PV team member’s participation on previous projects, were followed closely and improved upon as needed and agreed to by client validation representatives.

Throughout the validation, the client received flexible and responsive service, which fully supported the optimization of project schedules and successful timing toward meeting pre-production deadlines.